Z-0181-2009

Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model...

Name: Z-0181-2009 Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model...
Creator: Biomet, Inc.
Published: 2008-07-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-07-28 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended... on 2008-07-28. The reason FDA records is "The pin and clip may fracture during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0181-2009
Status: Terminated
Initiated: 2008-07-28
Posted: 2008-10-24
Terminated: 2009-09-22
Recalling firm: Zimmer GmbH
Product: Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The pin and clip may fracture during use.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance.
Quantity in commerce: 85
Distribution: Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.
Product codes and lots: Lot 097525, 097526, 532370 and 532810.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)